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Last Updated on: 28th July 2023, 07:22 pm
Pharmacists serve an important role in the healthcare system. But they also operate in a highly regulated environment. Pharmacies and pharmacists must strictly follow rules governing the dispensing of controlled substances and other drugs. State boards of pharmacy and the federal Drug Enforcement Administration (DEA) oversee compliance.
If the DEA or state pharmacy board targets you for an audit or investigation, your livelihood may be on the line. These in-depth reviews examine your records, dispensing practices, inventories, security protocols, and more. The stakes are high if violations are found, with discipline ranging from fines to license suspension or revocation.
With the right preparation, you can effectively respond to a board of pharmacy or DEA investigation. Here is what pharmacists need to know to come through scrutiny with their reputation and career intact.
Before we get into preparation strategies, it’s useful to understand what puts pharmacists on investigators’ radar in the first place. Some of the most common red flags include:
With risks like that, it pays to be cautious in your dispensing practices. But you should also know your rights and be ready to respond if an audit or complaint does trigger an investigation.
If you get word of a pending DEA or board of pharmacy investigation, you’ll need to take proactive steps:
Secure experienced legal counsel – Your first priority should be retaining an attorney experienced in representing pharmacists and pharmacies before the DEA and state regulatory boards. They’ll advocate for your interests every step of the way.
Cooperate fully – Be responsive to all requests for records, interviews, pharmacy visits, inventories, surveillance footage, or other information. Lack of cooperation is grounds for charges. Answer investigators’ questions directly but provide minimal extraneous information.
Conduct an internal audit – Re-examine your records, inventories, dispensing data, documentation practices, recordkeeping, security protocols, and personnel matters. Know precisely what investigators will find. Refine policies and practices where needed.
Consider negotiation – In some cases, it may be advantageous to try negotiating a settlement to avoid draconian sanctions. This is where experienced pharmacy regulatory counsel can guide you.
Prepare your defense – If negotiations fail, prepare to defend yourself at an administrative hearing. Your lawyer will demonstrate compliance, argue that charges are unfounded, and present mitigating circumstances. You may also leverage stellar records of dispensing safely and preventing diversion.
Obtain supporting experts – Qualified pharmacy practices experts can be engaged to independently review your records and operations and testify to their appropriateness. Their objective opinions often sway decisions.
Appeal adverse actions – If the ruling goes against you, all is not lost. Decisions can frequently be appealed or modified. Dedicated counsel will fight to overturn or reduce penalties. With preparation and perseverance, you can achieve the best possible outcome when facing a DEA or board investigation.
Navigating DEA and board of pharmacy investigations is challenging. Having the right lawyer can level the playing field. Be sure to look for these traits:
The pharmacy law group at Spodek Law meets each criteria. Their veteran attorneys offer deep pharmacy regulatory defense experience. Leveraging pharmacy expertise, negotiation skills, and diligent advocacy, they routinely secure positive outcomes for pharmacists facing DEA and board investigations nationally.
Don’t leave your career and reputation to chance. If you’re facing a DEA or state board of pharmacy investigation, consult a respected pharmacy law firm like Spodek. Their battle-tested lawyers will protect your interests, license, and livelihood at every turn.
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